510(k) · Cleared
ClearedHemosIL Silica Clotting Time
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GFO Activated Partial Thromboplastin
Cleared on Mar 16, 2016 as substantially equivalent to K050221 (Instrumentation Laboratory CO, 2005) after a 28-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Mar 16, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- GFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922156 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK922156 Lucor Confirmatory ReagentGradipore, Ltd. · 1993
- 2 generations backK990302 IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm…Instrumentation Laboratory CO · 1999
- 1 generation backK050221 Hemosil Silica Clotting TimeInstrumentation Laboratory CO · 2005
- This deviceK160445 HemosIL Silica Clotting TimeInstrumentation Laboratory CO · 2016
- Descendant · cites it directly · 0 of its ownK253957 HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922156 | Lucor Confirmatory Reagent | Gradipore, Ltd. | 1993 | — |
| −2 | K990302 | IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims… | Instrumentation Laboratory CO | 1999 | — |
| −1 | K050221 | Hemosil Silica Clotting Time | Instrumentation Laboratory CO | 2005 | — |
| 0 (this device) | K160445 | HemosIL Silica Clotting Time | Instrumentation Laboratory CO | 2016 | — |
| +1 | K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GFO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GFO device
- #1 K253957 HemosIL Silica Clotting Timescore 11.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050221 | Hemosil Silica Clotting TimeSummary page 4…Hematology (81) Product Code: GFO Predicate Device HemosIL Silica Clotting Time 510(k) No.: K050221 Device Indications for Use / HemosIL Silica Clotting Time is intended for the detection of Lupus Intended Use… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253957 | HemosIL Silica Clotting Time | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K253957 (Instrumentation Laboratory (IL) Co., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GFO devicesGFO Activated Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GFO
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GFO
Too few GFO 510(k)s in any year since 2007 to give a median.
Recalls per year · GFO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GFO
14in 2025
MAUDE reports naming product code GFO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 1 | 14 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
HemosiL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160445: HemosIL Silica Clotting Time.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160445
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026